SOLICITATION NOTICE
A -- RECOVERY-PD Tests in Phase 0 Clinical Trials - RECOVERY - ST10-1096
- Notice Date
- 6/18/2010
- Notice Type
- Presolicitation
- NAICS
- 541711
— Research and Development in Biotechnology
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Bldg 427, Room 12, Frederick, Maryland, 21702
- ZIP Code
- 21702
- Solicitation Number
- RECOVERY-ST10-1096
- Archive Date
- 8/14/2010
- Point of Contact
- Howard R. Souder, Jr., Phone: 3018465096
- E-Mail Address
-
souderhr@mail.nih.gov
(souderhr@mail.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- This pre-solicitation notice is being provided as intent of a future Request For Proposal (RFP) is being considered for release. Any questions concerning any additional details are to be SUBMITTED IN WRITING by email to the Subcontracts Specialist listed on this notice. PLEASE REFER TO THE ATTACHED DOCUMENT FOR ACCESS TO THE LINKS OUTLINED IN THIS NOTICE. PRESOLICITATION ANNOUNCEMENT FOR REQUEST FOR PROPOSAL (RFP) - ST10-1096 This Announcement is issued by SAIC-Frederick (SAIC-F) in support of its prime contract awarded by the National Cancer Institute at Frederick (NCI-F). For more information regarding this relationship, see www.ncifcrf.gov. This document should not be construed as a solicitation or as an obligation on the part of SAIC-F, or the Government. SAIC-F does not intend to award a subcontract(s) on the basis of responses to this Anouncement, nor pay for the preparation of information provided herein. _____________________________________________________________________________ A. PURPOSE AND INTENT OF THIS ANNOUNCEMENT The purpose of this Announcement is to provide potential subcontractors with notification of a request for proposal to follow within the next 30 days. This Announcement references a Request for Information RFI - Pharmacodynamic (PD) tests into Phase 0 clinical trials. The Division of Cancer Treatment and Diagnosis (DCTD) at NCI-F will promote the introduction of promising cancer therapeutics through the integration of appropriate pharmacodynamic (PD) tests into Phase 0 clinical trials with the focus on gathering evidence of targeted drug action that enables early Go/NoGo decisions. This Announcement notifies non-profit organizations, academics, clinical centers, and industry on the following topics: 1. Technologies and key cancer related pharmacodynamic targets for the next generation of PD assays that are to be developed using readily clinically adoptable state-of-the-art tools. a. Utilization of multiplexed assay platforms that enable multiple PD readouts from small amounts of specimens coupled with robust annotation and data management to include: multi-channel microscopy, ELISAs, Laser Capture, PCR, etc. The goal is to maximize the amount of PD information that can be obtained from a single specimen. Combinatory markers have the greatest potential for providing valid and clinically relevant drug action and patient response information in genetically diverse populations. b. The next generation of PD Assays must query multiple validated cancer specific analytes simultaneously to include the following categories: 1) Interrogate multiple targets within a molecular pathway, such as cellular signaling in the PI3K/Akt/PTEN axis, the glycolysis pathways, NOTCH and RAS pathways. DNA repair,and early markers of Apoptosis. 2) An assay platform to focus on quantitative multiplex assays in appropriate formats, e.g., tissue slides and cell extracts. 3) Development of new technologies and platforms for Circulating Tumor Cells (CTC). 4) Quantify multiple molecular events on the same target molecule, for example, activating and suppressing modifications of individual Akt isozymes or multiple phosphorylation sites on the MET receptor. 5) Filter target detection and quantitation to allow measurement in specific cellular compartments (e.g.plasma membrane and nucleus). c. Establish an infrastructure to provide access to key reagents (antibodies & probes, calibrators, references, etc), specimens (repositories, storage, processing, etc)), and accessory technologies (software, robotics, etc) that are essential for development of robust, sensitive, reproducible tests. This topic includes quality controlled production of critical reagents, regulatory (FDA/CLIA/CAP) knowledge and compliance, pattern recognition software, data analysis software that gives easily interpretable results, nanotechology for biopsies, and much more. 2. Opportunities to respond to, and participate in, future subcontracting events in support of the pharmacodynamic assay initiative. 3. Opportunities to bid upon solutions in the core areas listed above, using their specific expertise. This Announcement precedes an anticipated RFP issuance within 21 days of the issuance of this notice, and serves as a notice for organizations to develop a productive strategy for building the PD assay infrastructure and assay portfolio with SAIC-F management of subcontracts. B. Respondent Instructions/Statement of Interest No response is required at this time. However, when the RFP is announced, bidders will be requested to detail their proposed solution(s). Responses to the RFP do not need to address all aspects of the forthcoming RFP. Proposals can address specific sections or a portion of the RFP (See Attachment_1). RFP issue date is anticipated to be within 21 days of the issuance of this notice. The format of your proposal should include the following Business Information in addition to capability statement: (See attachment_2). C. Program Summary. (See attachment_3) D. Intellectual Property. (See attachment_4) E. American Recovery and Reinvestment Act (ARRA). It is intended that the aforementioned RFP will be appropriated through funding under ARRA. Additional reporting and compliance requirements will be detailed within the formal RFP announcement. Any offeror who is not willing to comply with the reporting and compliance requirements outlined in the Act, will not be included for consideration. F. Point of Contact Mr. Howard Souder, Jr., Subcontract Specialist, Phone (301) 846-5096, Fax (301) 228-4037, Email souderhr@mail.nih.gov Attachment 1 Organizations wishing to respond should submit the following: 1. A statement of your company's, non-profit organization's, clinical center's, or laboratory's participation in the PD program through a future subcontract agreement in support of the PD Assay initiative. 2. A summary of your company's, non-profit organization's, clinical center's, or laboratory's comments on the PD program, proposals on strategy and operational aspects if warranted, any other comments or observations you feel will enhance the value proposition and positive outcomes of the program. 3. A description of your organization's technical and scientific expertise as it relates to the topics described in the referenced RFI. 4. A proposal that will agree to work with DCTD to promote the clinical use of jointly developed PD assays to include possible future commercialization. Indicate what types of governance will your organization require for drafting contracts with SAIC-F/NCI-F. 5. Indicated whether the biotech best practices model of running this program via a joint project team, Project Web Access Enterprise communication and transparency; and facilitated by a Project Manager that develops clear timelines, budgets and product criteria would be acceptable for running the partnership. 6. Your belief that the proposed PD assay initiative will address any unmet needs in the cancer care community and facilitate the movement of promising molecular drugs into and through the clinical setting. Offerors must submit via email a capability statement (25 page limitation, excluding resumes) describing their organization's experience and abilities to provide the materials and services as described which includes: (1) a summary of list of past performance with references; (2) a brief description of the professional qualifications and experience of key staff who may be assigned in the production of the materials and delivery of services (CV's may be provided); (3) listing of any/all current and relevant certifications from a qualified neutral third-party and contact information; (4) a general description of the facilities and other resources needed to provide the materials and services; (5) demonstrated ability to produce the materials & services; and (6) an estimated cost broken down in a Cost-Reimbursement Plus Fixed-Fee(CPFF) format of defined materials and services. Brevity and a structured format (such as bulleted items) are encouraged whenever applicable to aid in processing. Back to: StatementOfInterest Attachment 2 Please include the following business information: 1) Request for Proposal Number 2) DUNS number 3) Company Name 4) Company Address 5) Company Point of Contact, Phone, FAX, and Email Address. POC's should include individual(s) who is(are) duly authorized in managing any/all technical issues and/or questions, and individual(s) who is(are) authorized in managing any/all contractual issues and/or questions. 6) Type of Company (i.e. small business, 8(a), woman-owned, veteran-owned, etc.) as validated by the Central Contractor Registration (CCR). All responders must register on the CCR, located at http://www.ccr.gov/index.asp. The issuance date of the RFP is anticipated to be within 21 days of the issuance of this notice. BACK to BusinessInformationFormat Attachment 3 PROGRAM SUMMARY 1. Pharmacodynamics Goal To dramatically increase the throughput of drug candidates evaluated in ‘First In Human' early Phase 0 and Phase I clinical trials, by providing Mechanism of Action data through PD assays that monitor drug effects on the defined target, enabling ‘early' data-driven decisions on the ‘drugability' of candidates. 2. Pharmacodynamics Vision The PD Assay initiative is to bring DCTD, academia, clinical centers, non-profits, and diagnostic and pharma industries together to facilitate ‘drug specific' assay development to meet pharmacodynamic needs over the next five years. The strategy is to leverage the knowledge and resources of these entities to create joint endeavors to develop high value PD assays that will have the biggest clinical impact in cancer patient care. This notice is a time-sensitive RFI regarding the feasibility of establishing an integrated pharmacodynamic network of government, industry, non-profits, clinical organizations, and academia with specific PD assay development skills, technology, reagent production, and other expertise to address unmet needs in cancer pharmacodynamics. The response to this RFI will be used to assess the feasibility of assembling a consortium of expertise to participate in development of DCTD's PD Assay program, to support the development of first-in-class, targeted molecular therapeutic agents. 3. Background The integration of molecular diagnostics as a tool for personalized medicine has been delayed due to economy, regulatory, healthcare insurers, clinical adoption, and other factors. Many of the assays and techniques introduced today may take years to replace the standard of care, especially with healthcare systems' emphasis on cost/benefit analysis for new technology adoption, the market value and thus implementation of newer approaches may be limited. One way that NCI-F can help with the introduction of these tests is to create incentives and provide support for companies, academia, clinical centers, and non-profit organizations to develop and launch PD assays with the required analytical and clinical validation. NCI-F through careful strategic action in the Pharmacodynamic arena can make a big impact in clinical medicine over the next 5 years by supporting the introduction of critical PD assays on clinically adoptable technology platforms. It is envisioned that the NCI-F will work with the organizations and companies in the joint development of robust pharmacodiagnostic assays for immediate clinical needs via collaboration and partnership. An example of this collaboration would be, in addition to funding, the provision of bulk critical reagents, calibrators, and positive and negative controls generated in NCI-F's laboratories and in GMP contracting and manufacturing facilities. Furthermore, NCI-F in association with National Cancer Centers will support the "clinical validation" in part through Phase 0/I drug trials, which can generate FDA-quality data for regulatory submissions. The clinical validation of an assay is critical to capture market share through widespread clinical adoption, as well as to obtain coverage by healthcare insurers. Although the type of partnership/collaboration will be unique for each assay and organization, the NCI-F will be able to assist the entity defray some of the costs and speed up the timeline for generating data required for CLIA laboratory adoption and/or 510K or PMA approval by leveraging NCI-F's resources and partners. The scientific and clinical expertise and novel technologies assembled within this PD initiative will expedite the development of promising new PD assays that will support cancer drug development and facilitate First-in-Human clinical trials under NCI-F sponsorship. The technology and assays must meet strict clinical value criteria to be advanced into the clinical setting, thus focusing NCI-F's resources on the most promising pharmacodynamic analytes. Strategic partnering of NCI-F with companies and organizations that have clinically adoptable technology and ‘Freedom to Operate' positions for key oncology target molecules will help to insure the success of DCTD's PD and Phase 0 initiatives. The following are links to NCI-F and NIH resources available for reference: DCTD: http://dctd.cancer.gov/ Biomarkers: http://dctd.cancer.gov/ResearchResources/ResearchResources-biomarkers.htm Clinical Validation Lab: http://dctd.cancer.gov/ProgramPages/DTP_NewInitiatives_Establishment.htm Phase 0: http://dctd.cancer.gov/MajorInitiatives/02NExT.htm NIH Roadmap: (http://www.cancer.gov/researchandfunding/NIHRoadmap) BACK to ProgramSummary Attachment 4 INTELLECTUAL PROPERTY (IP) Please note that IP will be further addressed in the SAIC-Frederick, Inc. Subcontract Agreement. The patent rights for inventions first produced in the performance of potential subcontracts will be governed by the Bayh-Dole Act as implemented by the Federal Acquisition Regulations (FAR) clause 52.227-11 Patent Rights (Dec 2007). Rights in data first produced in the performance of potential subcontracts will be governed by FAR 52.227-14 Rights in Data (Dec 2007). Although the management of patent rights for inventions produced under the pharmacodynamic assay initiative will be governed by the Bayh-Dole Act, effective sharing of resources and data are considered to be imperative to the success of the overarching NCI-F program. Furthermore, it is essential that some guarantee of IP management that facilitates and promotes the discovery and development of therapeutic and diagnostic candidates in this regard is provided. BACK to IntellectualProperty
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- Place of Performance
- Address: Subcontractor's location - TBD, United States
- Record
- SN02181874-W 20100620/100618234623-19bb4b96121420e1bed50688f7632138 (fbodaily.com)
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